Senior Systems Engineer

We are seeking a Senior Systems Engineer to provide technical leadership across the product lifecycle, from concept and development through verification, validation, launch, and sustaining. The ideal candidate will have strong experience in systems engineering, requirements management, risk analysis, system integration, and V&V within a regulated product environment.

Key Responsibilities

• Lead system-level engineering activities throughout the product lifecycle.
• Develop, manage, and maintain system requirements and traceability across hardware, software, and integrated systems.
• Lead system integration, design reviews, risk assessments, FMEA, and hazard analysis.
• Develop and coordinate verification & validation (V&V) strategies, plans, and execution.
• Identify and resolve complex system-level technical and product performance issues.
• Collaborate with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, Clinical, and Operations teams.
• Support reliability engineering, technical risk mitigation, and continuous improvement initiatives.
• Provide technical leadership and mentorship to engineering teams.
• Apply Design for Six Sigma (DFSS) and systems engineering best practices.

Required Skills & Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field.
• 3–5+ years of relevant engineering/systems engineering experience.
• Proven experience with systems engineering, requirements management, and traceability.
• Hands-on experience with system-level verification and validation (V&V).
• Strong knowledge of FMEA, hazard analysis, risk management, and risk mitigation.
• Experience with system integration and cross-functional product development.
• Strong technical problem-solving, documentation, communication, and presentation skills.
• Ability to lead and influence cross-functional engineering teams.

Preferred

• Experience developing medical devices or other regulated products.
• Experience with software-enabled or connected products.
• Familiarity with Jama, DOORS, Polarion, or similar requirements tools and MBSE concepts.
• Knowledge of ISO 14971, DFSS, reliability engineering, or statistical methods.
• Experience working in Agile or hybrid product development environments.